---
title: 'Sr. Manager, LVV Manufacturing at Genetix Biotherapeutics'
canonical: 'https://feeny.ai/job/sr-manager-lvv-manufacturing-genetix-biotherapeutics-somerville-z0yp801tagkj'
type: 'job'
last_seen: '2026-11-02'
---

# Sr. Manager, LVV Manufacturing at Genetix Biotherapeutics

- **Company:** Genetix Biotherapeutics
- **Location:** Somerville, MA
- **Compensation:** $155k–$165k
- **Posted:** 2026-10-21
- **Last confirmed live:** 2026-11-02
- **Apply:** https://job-boards.greenhouse.io/genetixbiotherapeutics/jobs/8306701

## Job description

## About Genetix Biotherapeutics

At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference. When you join Genetix, you're not just landing a new role, you become part of a company that's pursuing curative gene therapies to give patients and their families more days. We are doers, thinkers and collaborators who embrace and live by our values:

Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.

This is a full-time hybrid position based in our Somerville, Massachusetts (Assembly Row) office, with an onsite presence required three days per week. Candidates must reside within a commutable distance of the office to be considered.

## SUMMARY

The Senior Manager, Lentiviral Vector (LVV) Manufacturing will provide hands-on operational leadership for GMP lentiviral vector manufacturing, ensuring reliable, compliant, on-time production to support commercial supply. This role is accountable for the day-to-day oversight of commercial LVV manufacturing at our contract development and manufacturing organization (CDMO), including master batch record (MBR) and executed batch record review, deviation and CAPA management, and change control, in close cross-functional partnership with Quality, Supply Chain, MS&T, Process Development, Analytical, and Regulatory functions.

The Senior Manager will serve as a key site liaison and person in plant (PIP) for manufacturing activities at the CDMO (as necessary), and will report to the Director, Lentiviral Vector Manufacturing and MS&T. This role will also be responsible for starting materials management. This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office. This role will also require occasional travel to manufacturing sites (<10% travel).

## RESPONSIBILITIES

Manufacturing Operations

- Provide operational oversight of GMP commercial LVV drug substance manufacturing at the CDMO, including campaign planning, batch readiness, and on-time execution
- Serve as day-to-day point of contact and site liaison to the CDMO for batch scheduling, execution, and issue resolution
- Review and approve MBRs and MBR revisions, and review executed batch records for accuracy, completeness, and GMP compliance to drive right-first-time execution and timely batch disposition
- Own deviations and investigations related to commercial LVV manufacturing, including review and approval of CDMO-initiated events, ensuring sound root cause analysis, product impact assessment, and timely closure
- Own CAPAs arising from manufacturing events, ensuring timely implementation and effectiveness checks
- Author, review, and approve change controls (CDMO-initiated and Genetix-initiated) affecting commercial LVV manufacturing, assessing process, quality, supply, and regulatory impact and coordinating implementation
- Review and approve CDMO documentation impacting manufacturing operations, such as SOP revisions, protocols, and reports
- Support inspection readiness and participate in regulatory and customer inspections

Supply & Performance Management

- Partner with Supply Chain to align production schedules, raw material availability, and capacity with commercial demand
- Track and report manufacturing performance metrics (e.g., on-time batch release, right-first-time, deviation rates, yield) and escalate risks to the Director
- Support continued process verification (CPV), data trending, and annual product quality review (PQR) activities for commercial LVV manufacturing, including data review and recommendations
- Identify and implement continuous improvement opportunities that improve yield, reliability, and cost of goods

Cross-Functional Collaboration

- Partner with Quality, Regulatory Affairs, MS&T, Process Development, and Analytical teams to support successful process changes, lifecycle activities, and resolution of manufacturing and quality events
- Provide manufacturing input to regulatory filings, responses, and lifecycle submissions related to LVV manufacturing changes
- Contribute to governance forums and lead or participate in joint CDMO operational and quality review meetings

Leadership & Collaboration

- Lead all LVV and starting material meetings, internally and externally.
- Foster a culture of accountability, continuous improvement, and technical rigor
- Build strong, collaborative working relationships with CDMO counterparts

## QUALIFICATIONS

Education and Experience

- Bachelor’s degree in Engineering, Life Sciences, or related field; advanced degree preferred
- 6+ years of experience in biopharma manufacturing, with at least 3 years in a people-leadership or supervisory role
- Strong preference for hands-on experience in GMP viral vector manufacturing (lentiviral vector experience preferred) and/or manufacturing oversight; broader cell and gene therapy experience also valued
- Experience working with or overseeing contract development and manufacturing organizations (CDMOs)
- Demonstrated experience reviewing batch records and managing deviations, CAPAs, and change controls in a GMP environment; commercial manufacturing experience preferred
- Working knowledge of GMP compliance, quality systems, and regulatory expectations for advanced therapies

## Skills and Competencies

- Proven ability to lead cross-functional work, manage multiple priorities, and influence without direct authority
- Working knowledge of cGMP, GDP, and regulatory requirements (FDA, EMA, ICH)
- Strong problem-solving, communication, and collaboration skills

## Key Attributes

- Hands-on, results-driven leader with strong technical grounding in LVV manufacturing
- Sound judgment and a bias toward accountability and follow-through

Additional Information

The pay transparency range provided below is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. We may ultimately pay more or less than the posted range, and the range may be modified in the future. This role is eligible for an annual bonus and long-term incentive. Actual base salary pay will be based on several factors, including but not limited to experience, skills, relevant education/qualifications, external market, internal equity, and other job-related factors permitted by law.

Genetix’s total rewards package also provides employees with a comprehensive and competitive benefits suite to support a variety of employee needs. These benefits include comprehensive health, life and disability insurance, employer-matched 401(k) plan, lifestyle spending account, flexible time-off + paid holidays and winter holiday period, tuition reimbursement & loan repayment assistance, paid parental leave, paid onsite parking, commuter subsidy, and much more.

Pay Transparency $155,000—$165,000 USD

Genetix is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment.  All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.

## About Genetix Biotherapeutics

## Company Overview
- **One-liner**: Genetix Biotherapeutics (formerly bluebird bio) is a commercial-stage biotechnology company dedicated to developing and delivering one-time, curative genetic therapies for patients with severe rare genetic diseases.
- **Entity Type**: Private (taken private in June 2025 after a sale to new ownership)
- **Headquarters**: Somerville, Massachusetts, USA (with a presence in the Netherlands)
- **Founded**: 1992 (founded as Genetix Pharmaceuticals; rebranded to bluebird bio in 2010; rebranded back to Genetix Biotherapeutics in September 2025)
- **Founders**: Not publicly disclosed; the company was originally founded as Genetix Pharmaceuticals in 1992.

## Core Business
- **Primary Industries**: Biotechnology, Gene Therapy, Rare Disease Therapeutics
- **Target Customers**: B2B (healthcare providers, qualified treatment centers, payers/insurers) and B2C (patients with sickle cell disease, β-thalassemia, and cerebral adrenoleukodystrophy)
- **Mission**: "To transform lives through curative therapies for patients with rare, genetic diseases."

## Products & Services
- **LYFGENIA™ (lovotibeglogene autotemcel / lovo-cel)**: An FDA-approved, one-time gene therapy for patients 12 years and older with sickle cell disease. It works by adding functional copies of a modified β-globin gene into the patient's own blood stem cells.
- **ZYNTEGLO™ (betibeglogene autotemcel)**: An FDA-approved, one-time gene therapy for patients with β-thalassemia who require regular blood transfusions. It adds functional copies of a modified β-globin gene into the patient's own blood stem cells.
- **SKYSONA™ (elivaldogene autotemcel)**: An FDA-approved, one-time gene therapy for boys with cerebral adrenoleukodystrophy (CALD), a rare, progressive genetic brain disease. It adds a functional copy of the ABCD1 gene into the patient's own blood stem cells.
- **Patient Support Program**: Personalized assistance for patients and families navigating the treatment journey, including insurance questions, treatment center coordination, and one-on-one support.

## Market Standing
- **Valuation/Market Cap**: Not publicly disclosed (privately held after take-private transaction in June 2025)
- **Key Metrics**:
  - **Annual Revenue**: Not publicly disclosed (but the company reported strong revenue growth in 2025 and achieved its **first ever profitable quarter** in that year)
  - **Total Funding**: Not publicly disclosed (new investors provided "significant capital" to support operational objectives following the take-private transaction)
- **Notable Investors/Partners**: New ownership group (undisclosed); manufacturing partners include **Minaris**, **Lonza**, and **MilliporeSigma** (the U.S. and Canada business of Merck KGaA, Darmstadt, Germany)
- **Growth Signals**:
  - **2025 commercial performance**: >100 patients treated in the U.S.; >150 patients completed their first cell collection cycle; 70 active Qualified Treatment Centers (QTCs) — the largest network for hemoglobinopathy gene therapies nationwide
  - **2026 outlook**: Doubling manufacturing capacity by mid-2026; targeting first full year of profitability; expanding LYFGENIA label to pediatric patients <12 years of age; advancing cryopreserved apheresis to improve the treatment experience

## Competitive Advantages
- **First-mover & market leader**: The only company with FDA approval for three gene therapies, and the market leader in the U.S. for hemoglobinopathy gene therapies
- **Proven commercial model**: >100 patients treated in a single year demonstrates real-world commercial execution and manufacturing scale
- **Decades of scientific innovation**: Over 30 years of R&D in genetic therapy, with extensive clinical data from hundreds of treated patients (including 15-year long-term follow-up studies)
- **Strong access**: LYFGENIA and ZYNTEGLO have meaningful access for >90% of eligible patients with commercial or Medicaid coverage
- **One-time curative approach**: Therapies are designed to treat the underlying cause of disease, offering durable, potentially life-long benefits from a single administration

## Strategic Focus
- **Commercial execution & patient access**: Expanding the Qualified Treatment Center network and making the treatment journey simpler for patients and providers
- **Manufacturing scale-up**: Doubling manufacturing capacity in 2026 through partnerships with CDMOs to meet growing patient demand
- **Process optimization**: Implementing cryopreserved apheresis to improve the patient and provider experience
- **Label expansion**: Advancing the HGB-210 Phase 3 study to bring LYFGENIA to pediatric sickle cell patients under 12 years of age
- **Full-year profitability**: Targeting the company's first full year of profitability in 2026

## Why Work Here
- **Mission-driven culture**: "United by purpose" — the company is laser-focused on transforming the lives of patients with rare, genetic diseases through curative therapies
- **Strong momentum**: Recently achieved first-ever profitable quarter, with rapid commercial growth and a clear plan for expansion in 2026
- **Remote/hybrid policy**: Roles are listed as both on-site (Somerville, MA) and remote (e.g., Account Manager, Gene Therapy) — flexible arrangements appear available depending on the role
- **Active hiring**: 23 job postings as of the search date, spanning Commercial, Quality Assurance, Technical Operations, Medical, and Regulatory functions
- **Experienced leadership**: Led by CEO David Meek (ex-Mirati Therapeutics, Ipsen) with a seasoned executive team of industry veterans, signaling strong strategic direction
- **Notable perks/culture**: High-impact work at the intersection of cutting-edge science and commercial execution; opportunity to join a company in the middle of a dramatic turnaround and growth phase; patient-centric focus with a dedicated support program

## Sources
1. [genetixbiotx.com - Company website](https://www.genetixbiotx.com/)
2. [job-boards.greenhouse.io - Careers page](http://job-boards.greenhouse.io/genetixbiotherapeutics)
3. [linkedin.com - LinkedIn company page](https://www.linkedin.com/company/genetix-biotherapeutics)
4. [genetixbiotx.com - Press release: Rebrand from bluebird bio](https://www.genetixbiotx.com/press-release-2025-09-18.html)
5. [genetixbiotx.com - Press release: 2025 commercial results & 2026 priorities](https://www.genetixbiotx.com/press-release-2026-03-02.html)

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